Leveraging Digital Health Solutions to Collect Patient-Reported Outcomes in Rectal Cancer
2 de setembro de 2026 atualizado por: University of California, San Francisco
Rectal cancer care is increasingly complex and may include systemic therapy, radiation therapy, surgery, or nonoperative watch-and-wait surveillance.
These treatments can have both short- and long-term effects on bowel, urinary, sexual, and stoma-related function.
Prior studies have often assessed quality of life and treatment decision experiences at a single time point or after one type of treatment, resulting in limited information about how patients' experiences change throughout their course of care.
This study will evaluate health-related quality of life and experiences with treatment decisions among patients with non-metastatic rectal cancer using validated patient-reported outcome measures over the course of treatment.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
PRIMARY OBJECTIVES:
- Evaluate feasibility and adherence of participant-reported outcomes through UCSF MyChart.
- Evaluate changes in health-related quality of life over the course of rectal cancer treatment.
SECONDARY OBJECTIVES:
- Evaluate longitudinal changes in decisional regret over the course of rectal cancer treatment.
- Evaluate the association between health-related quality of life and decisional regret over the course of rectal cancer treatment.
- Evaluate differences in health-related quality of life and decisional regret trajectories by treatment stage and modality.
- Evaluate patterns of survey completion and adherence to the MyChart survey workflow.
OUTLINE: This is a prospective observational study of adults with non-metastatic rectal cancer receiving care at University of California, San Francisco (UCSF). Participants will complete patient-reported outcome measures through UCSF MyChart during the course of their treatment and will be follow up to 24 month post treatment.
Tipo de estudo
Observacional
Inscrição (Estimado)
150
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Laleh Foroutani, MD
- Número de telefone: (415) 299-9424
- E-mail: laleh.foroutani@ucsf.edu
Locais de estudo
-
-
California
-
San Francisco, California, Estados Unidos, 94143
- University of California, San Francisco
-
Contato:
- Laleh Foroutani, MD
- Número de telefone: 415-299-9424
- E-mail: laleh.foroutani@ucsf.edu
-
Investigador principal:
- Mark Zhao, MD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
Adults with non-metastatic rectal cancer receiving treatment at University of California, San Francisco (UCSF).
Descrição
Inclusion Criteria:
- Adults age 18 years or older meet all of the following.
- Documented rectal cancer diagnosis (for example, ICD-10-CM C20) without metastatic disease at the initial study eligibility assessment.
- Established follow-up with UCSF colorectal surgery, medical oncology, or radiation oncology, generally defined as at least two encounters more than 1 month apart.
- Active UCSF MyChart access by enrollment and ability to personally complete the electronic consent and surveys, independently or with reasonable technical or accessibility assistance that does not answer questions on the participant's behalf. Individuals identified through PRP direct mail who do not yet use MyChart may activate MyChart before enrollment.
- Able to read and complete the currently validated English-language study materials.
- Able to provide informed consent and HIPAA authorization.
Exclusion Criteria:
- Metastatic disease at the initial eligibility assessment.
- Unable or unwilling to activate and personally use UCSF MyChart before enrollment, even with reasonable technical or accessibility assistance.
- Unable to complete the English-language consent and validated instruments. This initial pilot is limited to English because validated translations and translated automated workflows are not yet available.
- No UCSF clinical encounter for more than 6 months or otherwise lost to follow-up.- Unable or unwilling to provide informed consent and HIPAA authorization.
- Prisoner at enrollment. If a participant becomes incarcerated or loses decision-making capacity after enrollment, active survey collection will stop.
Participants who develop metastatic progression after enrollment are not treated as screen failures; they will receive one final general ABCRC module and then exit the automated survey sequence.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Participants with rectal cancer
Participants with non-metastatic rectal cancer and who are receiving treatment at UCSF.
|
Patient-reported outcome measures: Assessment of Burden in Colorectal Cancer (ABCRC) & Decisional Regret Scale (DRS)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of scheduled MyChart survey events completed
Prazo: Up top 12 months
|
The proportion of scheduled MyChart survey events completed by participants will be summarized, with a target completion rate of at least 75%.
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Up top 12 months
|
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Change in mean ABCRC total and module-specific scores over time.
Prazo: Up to 12 months
|
Changes in Assessment of Burden in Colorectal Cancer (ABCRC) total and module-specific scores will be evaluated from enrollment and in relation to key treatment events.
Statistical models that account for multiple measurements from the same participant will be used to evaluate changes in scores over time.
|
Up to 12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in mean DRS score and proportion of participants with clinically significant decisional regret
Prazo: Up to 12 months
|
Longitudinal changes in Decisional Regret Scale (DRS) scores will be evaluated over the course of treatment using statistical models that account for multiple measurements from the same participant.
The proportion of participants with clinically significant decisional regret, defined as a DRS score greater than 50, will also be summarized.
|
Up to 12 months
|
|
Association between ABCRC and DRS scores over the course of treatment
Prazo: Up to 12 months
|
The relationship between Assessment of Burden in Colorectal Cancer (ABCRC) scores and Decisional Regret Scale (DRS) scores will be evaluated using repeated measurements collected from each participant.
The analysis will examine whether participants with different levels of quality of life also report different levels of decisional regret, and whether changes in quality of life are related to changes in decisional regret within the same participant over time.
Statistical methods that account for repeated measurements will be used.
|
Up to 12 months
|
|
Change in mean ABCRC and DRS scores over time by treatment characteristics
Prazo: Up to 12 months
|
Changes in ABCRC and DRS scores will be evaluated and compared among participants receiving different treatments, including surgery, watch-and-wait surveillance, treatment sequence, and surgical procedure.
Statistical models that account for multiple measurements from the same participant will be used to evaluate differences in score changes over time.
|
Up to 12 months
|
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Patterns of survey nonresponse, missingness, and workflow adherence
Prazo: Up to 12 months
|
Patterns of survey completion, nonresponse, missing data, and adherence to scheduled MyChart survey events will be described over the course of treatment.
Missing information will be summarized and evaluated to understand how missing surveys or responses may vary over time and by participant or treatment characteristics.
|
Up to 12 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Mark Zhao, MD, University of California, San Francisco
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
31 de outubro de 2026
Conclusão Primária (Estimado)
30 de novembro de 2027
Conclusão do estudo (Estimado)
30 de novembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
2 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
2 de setembro de 2026
Primeira postagem (Real)
9 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 264516
- NCI-2026-06213 (Identificador de registro: NCI Clinical Trials Reporting System (CTRP))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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